# K072913: Securmark Biopsy Site Identification System

- Pathway: 510(k) (Special)
- Applicant: Suros Surgical Systems, Inc. A Hologic Company
- Decided: Jan 4, 2008 after 84 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001807 (2001). 5 ancestors in all.
10 later devices descend from it; 2 cite it directly.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062528: Tissue Site Marking System, Suros Surgical Systems, Inc. (2007) Summary page 1.
- K042296: Biomarc Preloaded Tissue Marker Device, Carbon Medical Technologies, Inc. (2004) Summary page 1.

## Most influential descendants
- K113202: Tissue Marker (2012), 8 descendants of its own
- K143484: BioZorb Marker (2015), 7 descendants of its own
- K152070: BioZorb LP Marker (2015), 5 descendants of its own
- K180640: SmartClip Soft Tissue Marker (2018), 1 descendant of its own
- K233639: SmartClip Secure Soft Tissue Marker (2024), 0 descendants of its own

## Indications for use
The SeCurMark Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.

Source page: https://510kreport.com/device/K072913
Methodology: https://510kreport.com/methodology